Search Results

Vashe® Wound Therapy Solution is intended for OTC use for management of minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin.

The subject device is a wound cleansing solution that is intended for cleansing, irrigating, debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings. The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris.

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) summary for the Vashe® Wound Therapy Solution, a wound cleansing solution, and a letter from the FDA confirming its substantial equivalence to predicate devices.

The information primarily focuses on:

• Device Identification: Trade Name, Common Name, Classification Name, Product Code.
• Submitter and Contact Information.
• Predicate Devices: A list of previously cleared devices to which Vashe® Wound Therapy Solution is compared for substantial equivalence.
• Device Description: What the device is and its mechanical action.
• Indications for Use: What the device is intended for (management of minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin).
• Substantial Equivalence Argument: How it is similar in function and intended use to the predicate devices.
• Non-clinical Performance: A brief mention that pre-clinical testing demonstrated biocompatibility.
• FDA Clearance Letter: Confirmation of substantial equivalence and regulatory information.

There is no mention of:

• Specific acceptance criteria (e.g., performance metrics, thresholds).
• A formal study designed to demonstrate the device meets acceptance criteria.
• Sample sizes for test sets or training sets.
• Data provenance.
• Number or qualifications of experts.
• Adjudication methods.
• MRMC comparative effectiveness study.
• Standalone algorithm performance.
• Type or establishment of ground truth.

The "Non-clinical Performance" section states: "Pre-clinical testing demonstrated biocompatibility of the Vashe® Wound Therapy Solution." This is the only mention of any testing, but it's limited to biocompatibility and does not involve performance metrics related to acceptance criteria for the indicated uses. The basis for clearance is substantial equivalence to already marketed predicate devices, not meeting specific performance criteria through a new clinical or benchmark study.

Ask a specific question about this device